Ex Parte CANNATA et al

Patent Trial and Appeal BoardJan 9, 2019

14323693 (P.T.A.B. Jan. 9, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/323,693 07/03/2014 66854 7590 SHAY GLENN LLP 2755 CAMPUS DRIVE SUITE 210 SAN MATEO, CA 94403 01/11/2019 FIRST NAMED INVENTOR Jonathan M. CANNATA UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 10860-515.200 I UM-5851 1092 EXAMINER NGUYEN, HIEN NGOC ART UNIT PAPER NUMBER 3793 NOTIFICATION DATE DELIVERY MODE 01/11/2019 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): info@shayglenn.com shayglenn_pair@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD ExparteJONATHANM. CANNATA, TIMOTHYL. HALL, ADAM D. MAXWELL, and DEJAN TEOFILOVIC 1 Appeal 2017-011731 Application 14/323,693 Technology Center 3700 Before DONALD E. ADAMS, ERIC B. GRIMES, and RICHARD M. LEBOVITZ, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. Â§ 134 involving claims to an ultrasound treatment method and an ultrasound therapy system, which have been rejected as anticipated or obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b). We reverse. STATEMENT OF THE CASE "Histotripsy ... is a technology where short, intense bursts of acoustic energy induce controlled cavitation (microbubble or bubble cloud formation) 1 Appellants identify the Real Parties in Interest as HistoSonics, Inc. and The Regents of the University of Michigan. Appeal Br. 2. Appeal 2017-011731 Application 14/323,693 within the focal volume. The vigorous expansion and collapse of these microbubbles mechanically homogenizes cells and tissue structures within the focal volume." Spec. ,r 4. The Specification discloses optimized sequences ... characterized by an initiation pulse which is designed to create a least a single acoustically generated nucleus (bubble), followed by a shock scattering pulse (hereafter referred to as a scattering pulse or scattering pressure waveform) after an optimized time delay to enable a shockwave to impinge upon the first bubble to create a bubble cloud. Id. ,r 11. Bubbles are also referred to as "cavitation nuclei." See id. ,r 43. Claims 1-3, 5, and 7-21 are on appeal. Claims 1 and 2 are illustrative and read as follows (emphasis added): 1. A method of treating tissue with ultrasound energy, comprising the steps of: delivering a first pulse of a Histotripsy excitation sequence from an ultrasound therapy transducer, the first pulse comprising an initiation pressure waveform configured to produce at least one bubble in the tissue; delivering a second pulse of the Histotripsy excitation sequence from the ultrasound therapy transducer, the second pulse comprising a scattering pressure waveform configured to interact with the at least one bubble within a life-cycle of the at least one bubble; and producing cavitation nuclei near the at least one bubble with the scattering pressure waveform. 2. The method of claim 1 wherein the scattering pressure waveform is delivered within 5 Âµs to 200 Âµs of the initiation pressure waveform. 2 Appeal 2017-011731 Application 14/323,693 The claims stand rejected as follows: Claims 1, 5, 7, and 16 under 35 U.S.C. Â§ 102(a)(l) as anticipated by Maxwell2 (Ans. 2); Claims 2, 3, 8-10, 12-15, and 17-20 under 35 U.S.C. Â§ 103 as obvious based on Maxwell (Ans. 5); and Claims 11 and 21 under 35 U.S.C. Â§ 103 as obvious based on Maxwell and Cain3 (Ans. 7). I The Examiner has rejected claims 1, 5, 7, and 16 as anticipated by Maxwell. The Examiner finds that Maxwell discloses every limitation of claim 1; specifically, that Maxwell discloses a method of treating tissue with ultrasound energy, comprising the steps of: delivering a first pulse of a Histotripsy excitation sequence from an ultrasound therapy transducer, the first pulse comprising an initiation pressure waveform configured to produce at least one bubble in the tissue (see pages 1888, 1892-1893 and Fig. 8); delivering a second pulse of the histotripsy excitation sequence from the ultrasound therapy transducer, the second pulse comprising a scattering pressure waveform configured to interact with the at least one bubble within a life-cycle of the at least one bubble (see pages 1888, 1892-1893 and Fig. 8); and producing cavitation nuclei near the at least one bubble with the scattering pressure waveform (see pages 1888, 1892-1893 and Fig. 8). Ans. 3. 2 Adam D. Maxwell et al., Cavitation clouds created by shock scattering from bubbles during histotripsy, 130 J. Acoustical Soc'y of Am. 1888 (2011). 3 US 2007 /0083120 A 1, published Apr. 12, 2007. 3 Appeal 2017-011731 Application 14/323,693 Appellants argue that "[t]he Examiner appears to be confusing the terminology of a cycle with that of a pulse or waveform. As is commonly known in the art, an ultrasound pulse or an ultrasound waveform can include one or more cycles." Appeal Br. 5. Appellants argue that "[t]he Maxwell waveform does not include multiple pulses. Instead, it is a single pulse that includes multiple cycles." Id. at 5-6. Appellants argue that the key distinction is that claims 1 and 16 require two separate or distinct pulses/waveforms: a first pulse to produce a bubble and a second pulse to interact with the bubble to produce cavitation nuclei near the bubble using the shock scattering mechanism. In contrast, Maxwell describes only a single, contiguous, 5-20 cycle pulse/waveform to produce cavitation. Id. at 6. We agree with Appellants that the Examiner has not shown that Maxwell discloses two separate pulses/waveforms-an initiation pressure waveform and a scattering pressure waveform-as required by claims 1 and 16. Maxwell states that "[t]o investigate the mechanism of cloud formation, high-speed photography was used to observe clouds generated during single histotripsy pulses. Pulses of 5-20 cycles duration were applied." Maxwell 1888, abstract ( emphasis added). Maxwell consistently describes its experiments as involving investigations of a single histotripsy pulse. For example, in describing its experimental apparatus, Maxwell states that "[t]he transducer was driven with a single pulse of 5 to 20 cycles duration." Id. at 1889-1890 ( emphasis added). Maxwell states that its Figure 2 shows a "3-cycle focal pressure waveform [pulse] of the histotripsy transducer used to generate bubble clouds .... Pulse lengths of 5-20 cycles were used in this study for 4 Appeal 2017-011731 Application 14/323,693 generating clouds." Id. at 1890, Fig. 2 legend. Addressing single bubble behavior, Maxwell states that "[ s Jingle cavitation bubbles were observed during all pulses .... Bubbles would usually become visible within the first or second cycle of the pulse, growing and collapsing .... Bubbles further distorted throughout the pulse." Id. at 1891, left col. Addressing bubble cloud formation, Maxwell states that a "bubble cloud did not start to form on the first cycle, but usually began forming within 3--4 cycles .... Clouds grew at a nearly linear rate axially once they began to form during a pulse, but the lateral width remained constant throughout most of the pulse." Id. at 1891, right col. Maxwell also states that "[b ]ubble clouds generated from a five cycle pulse extended 1.4 +/- 0.4 mm axially and 1.4 +/- 0.25 mm laterally, while clouds from a 20 cycle pulse were 4.8 +/- 1.1 mm axially and 1.8 mm+/- 0.2 mm laterally." Id. at 1891- 1892. Thus, Maxwell describes its experiments as investigating the formation and behavior of bubbles and bubble clouds during a single histotripsy pulse with a pulse length of between 5 and 20 cycles. Maxwell does not describe its experiments as including two separate pulses, as required by claims 1 and 16. Maxwell therefore does not anticipate the claimed methods. See In re Skvorecz, 580 F.3d 1262, 1266 (Fed. Cir. 2009) ("Anticipation requires that all of the claim elements and their limitations are shown in a single prior art reference."). The Examiner reasons that "delivering multiple separate or distinct pulses/waveform (first and second pulses/waveform) to create and maintain bubbles ... is well-known in the field," as shown by the Introduction section 5 Appeal 2017-011731 Application 14/323,693 of Maxwell. Ans. 8. The Examiner concludes that "[ u ]sing first and second pulses to create and maintain is already known and can be seen as intuitively obvious in a common sense way." Id. at 9. Whether a person of ordinary skill in the art would have considered using two separate pulses intuitively obvious might be relevant to a rejection based onÂ§ 103, but it is not a sufficient basis to support a rejection based on Â§ 102, which requires identical disclosure of all of a claim's limitations. See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008) (To anticipate "it is not enough that the prior art reference discloses part of the claimed invention, which an ordinary artisan might supplement to make the whole."). See also id.: "[U]nless a reference discloses within the four comers of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. Â§ 102." For the reasons discussed above, we reverse the rejection of claims 1, 5, 7, and 16 under 35 U.S.C. Â§ 102(a)(l) as anticipated by Maxwell. II The Examiner has rejected claims 2, 3, 8-10, 12-15, and 17-20 as obvious based on Maxwell, and has rejected claims 11 and 21 as obvious based on Maxwell and Cain. Claims 2, 3, and 8-15 depend (directly or indirectly) from claim 1. Claims 1 7 and 18 are independent, and both claims require separate initiation and scattering pulses, with the scattering pulse delivered within 5 Âµsand 200 Âµs of the initiation pulse. Claims 19-21 depend from claim 18. 6 Appeal 2017-011731 Application 14/323,693 Thus, all of the claims rejected under 35 U.S.C. Â§ 103 also require the separate pulses that are missing from Maxwell's disclosure. The Examiner's statements of the Â§ 103 rejections does not provide a reason why a person of ordinary skill in the art would have considered the required modification of Maxwell to be obvious. Although the Examiner, in responding to Appellants' arguments, stated that "[u]sing first and second pulses to create and maintain is already known and can be seen as intuitively obvious in a common sense way," Ans. 9, "rejections on obviousness grounds cannot be sustained by mere conclusory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR!nt'l Co. v. Teleflex Inc., 550U.S. 398,418 (2007). The Examiner has not provided the required articulated reasoning with rational underpinning, and therefore has not made out a prima facie case of obviousness under Â§ 103. We therefore reverse the rejection of claims 2, 3, 8-10, 12-15, and 17-20 under 35 U.S.C. Â§ 103 based on Maxwell and the rejection of claims 11 and 21 under 35 U.S.C. Â§ 103 based on Maxwell and Cain. SUMMARY We reverse all of the rejections on appeal. REVERSED 7